Medtronic (NYSE:MDT) said today it launched a new clinical trial evaluating the use of its ECG belt research system as a diagnostic tool for improving cardiac resynchronization therapy for heart failure patients.
The Fridley, Minn.-based company said it has enrolled the first patients in the trial at Des Moines, Iowa’s Mercy Medical Center – West Lakes by principal investigator Dr. Troy Hounshell.
“The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits. By pairing CRT with the ECG Belt, we have the potential to provide a more personalized and noninvasive approach to help heart failure patients,” Dr. Hounshell said in a press release.
The ECG Belt for CRT Response trial aims to enroll 400 patients at 10 US centers to compare patients treated with both the ECG belt diagnostic and CRT against those treated with standard CRT alone, Medtronic said.
Trial investigators will use the ECG belt during the trial to analyze the heart electrical activity through real-time synchronization measurements, as well as during CRT implant to help guide placement of the left ventricular lead, Medtronic said.
“Our goal for this study is to give clinicians real-time insights to address each patient’s needs, and to help optimize CRT for heart failure patients,” CRT biz GM Dr. Kweli Thompson said in a prepared statement.
Last week, Medtronic said it won expanded FDA labeling for its SelectSecure MRI SureScan model 3830 cardiac pacing leads, now approved for His-bundle pacing.